Platinum-Based Chemotherapy With/Without INCMGA00012, an Anti-PD-1 Antibody, in Non-Small Cell Lu… (NCT04205812) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Platinum-Based Chemotherapy With/Without INCMGA00012, an Anti-PD-1 Antibody, in Non-Small Cell Lung Cancer
United States, Brazil583 participantsStarted 2020-09-11
Plain-language summary
The purpose of this study is to assess the efficacy and safety of platinum-based chemotherapy with or without INCMGA00012 in participants with metastatic squamous and nonsquamous non-small cell lung cancer (NSCLC).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Histologically or cytologically confirmed NSCLC (either nonsquamous or squamous) that is Stage IV (AJCC v8).
* No prior systemic treatment for the advanced/metastatic NSCLC
* Able to provide a formalin-fixed archival tumor tissue sample during screening, or a fresh tumor biopsy
* Measurable disease per RECIST v1.1.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Life expectancy of at least 3 months.
* Willingness to avoid pregnancy or fathering children.
* Adequate organ function as indicated by protocol-specified laboratory values. - Has been fully vaccinated against SARS-CoV-2 or is willing and able to be fully vaccinated against SARS-CoV-2 during the study by starting the vaccination process during screening.
Exclusion Criteria:
* Clinically significant cardiac disease within 6 months of start of study treatment.
* Any major surgery within 3 weeks of the first dose of study treatment.
* Thoracic radiation therapy of \> 30 Gy within 6 months of the first dose of study treatment.
* History of peripheral neuropathy ≥ Grade 2 CTCAE v5 for participants who may receive cisplatin, paclitaxel, or nab-paclitaxel.
* Untreated central nervous system metastases and/or carcinomatous meningitis.
* Evidence or history of interstitial lung disease or noninfectious pneumonitis that required systemic steroids.
* Active infection requiring systemic therapy or active tuberculosis. Note: If required by country or local regulations to be test…